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VAERS ID: 2272638

AGE: 73| SEX: F|State: FR

Description

COVID-19 respiratory infection; Vaccination failure; This case was received via regulatory authority on 06-May-2022 and was forwarded to Moderna on 06-May-2022. This regulatory authority case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19 respiratory infection) and VACCINATION FAILURE (Vaccination failure) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for COVID-19 vaccination. The patient's past medical history included Helicobacter pylori gastritis, Incontinence, Fracture vertebral and Knee prosthesis insertion. Concurrent medical conditions included Osteoporosis, Biliary cirrhosis primary, Sleep apnoea syndromes, Hypertension arterial and Myasthenia. Concomitant products included FOSFOMYCINE, CANDESARTAN CILEXETIL, PYRIDOSTIGMINE BROMIDE (MESTINON), PREDNISOLONE METASULFOBENZOATE SODIUM (SOLUPRED ORO), URSODEOXYCHOLIC ACID (DELURSAN) and LANSOPRAZOLE for an unknown indication. On 14-May-2021, the patient received first dose of TOZINAMERAN (COMIRNATY) (Intramuscular) .3 milliliter. On 22-Jun-2021, received second dose of TOZINAMERAN (COMIRNATY) (Intramuscular) dosage was changed to .3 milliliter. On 21-Dec-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 19-Mar-2022, the patient experienced COVID-19 (COVID-19 respiratory infection) (seriousness criterion hospitalization) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19 respiratory infection) and VACCINATION FAILURE (Vaccination failure) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication was reported. R1 was reported in dosage text for Spikevax. Company comment: This regulatory case concerns a 73-year-old female patient with no relevant medical history, who experienced the unexpected, serious (Hospitalization) adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 88 days after receiving the third dose of mRNA-1273 Vaccine. Additionally, Vaccination Failure was also reported. The initial two doses of Comirnaty were given approximately 6 months prior, the interval between the first and second doses was noted to be 39 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case seriousness was assessed as per Regulatory Authority report.; Sender's Comments: This regulatory case concerns a 73-year-old female patient with no relevant medical history, who experienced the unexpected, serious (Hospitalization) adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred 88 days after receiving the third dose of mRNA-1273 Vaccine. Additionally, Vaccination Failure was also reported. The initial two doses of Comirnaty were given approximately 6 months prior, the interval between the first and second doses was noted to be 39 days. Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case seriousness was assessed as per Regulatory Authority report.

Symptoms

COVID-19, Vaccination failure

Vaccines

VAX DATE: 13 May 2021 | ONSET DATE: 18 March 2022 | DAYS TO ONSET: 309
Vaccine TypeManufacturerVaccine NameDoseRouteSiteLot
  • COVID19
  • MODERNA
  • PFIZERBIONTECH
  • COVID19 (COVID19 (MODERNA))
  • COVID19 (COVID19 (PFIZER-BIONTECH))
  • 2
  • UNK
  • OT

RECVDATE:11 May 2022
CAGE_YR:
CAGE_MO:
RPT_DATE:
DIED:
DATEDIED:
L_THREAT:
ER_VISIT:
HOSPITAL:Y
HOSPDAYS:
X_STAY:
DISABLE:
RECOVD:N
LAB_DATA:
V_ADMINBY:UNK
OTHER_MEDS:FOSFOMYCINE; CANDESARTAN CILEXETIL; MESTINON; SOLUPRED ORO; DELURSAN; LANSOPRAZOLE
CUR_ILL:
HISTORY:Medical History/Concurrent Conditions: Biliary cirrhosis primary; Fracture vertebral; Helicobacter pylori gastritis; Hypertension arterial; Incontinence; Knee prosthesis insertion; Myasthenia; Osteoporosis; Sleep apnoea syndromes
PRIOR_VAX:
SPLTTYPE:FRMODERNATX, INC.MOD20225
FORM_VERS:2
TODAYS_DATE:10 May 2022
BIRTH_DEFECT:
OFC_VISIT:
ER_ED_VISIT:
ALLERGIES:
V_FUNDBY:
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